FAP-targeted PET/NIR in Lung Malignant Tumors

March 26, 2026 updated by: Chen KeZhong, Peking University People's Hospital

Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation

Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET/fluorescence were compared and analyzed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, exploratory clinical study designed to evaluate the role of FAP-targeted imaging in efficacy prediction and tumor bed delineation in patients with NSCLC undergoing surgical resection after neoadjuvant therapy. Following neoadjuvant treatment, enrolled patients will undergo preoperative FAP-targeted PET imaging to assess treatment response and identify metabolically active tumor-associated stromal regions. Surgical resection will be performed according to standard clinical practice. Immediately after tumor resection, ex vivo fluorescence imaging of the surgical specimen will be conducted using a EB-FAPI fluorescence probe. Based on fluorescence signal distribution, systematic multipoint sampling will be performed across tumor center, tumor margin, and adjacent normal tissues. Routine pathological sampling will be conducted in parallel according to standard protocols. Additional fluorescence-guided sampling will be performed in regions with persistent fluorescence signals. Histopathological analysis will be used as the reference standard to evaluate tumor bed distribution, residual tumor presence, and pathological response. The concordance between fluorescence imaging, PET imaging, and pathological findings will be analyzed. The study will also evaluate whether fluorescence-guided sampling can improve detection of residual tumor and reduce false-negative pathological assessments. This study aims to establish a multimodal imaging approach integrating preoperative molecular imaging and intraoperative fluorescence guidance to enhance tumor bed visualization and improve the accuracy of pathological response assessment after neoadjuvant therapy in NSCLC.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy

Description

Inclusion Criteria:

  • Age between 18 and 70 years old;
  • Have complete clinical and imaging data;
  • Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer;
  • Able to retain sufficient tumor tissue for testing and research;
  • Sign informed consent.

Exclusion Criteria:

  • Previously combined with other malignant tumors or received other anti-tumor treatments;
  • Failure to collect sufficient tumor tissue for testing and research;
  • The duration of neoadjuvant therapy is less than 3 cycles;
  • The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing;
  • Lack of clinical and imaging data;
  • There are situations where other researchers consider it inappropriate to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FAP-targeted PET in lung malignant tumors
Participant who conforms to the inclusion criteria will undergo 68Ga-FAPI/EB-FAPI PET/CT scans within 1 week.
Diagnostic test: PET/CT scans
PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy
Time Frame: From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)
To evaluate the accuracy of intraoperative FAP-targeted fluorescence imaging in identifying the tumor bed after neoadjuvant therapy in NSCLC patients, using histopathological assessment as the reference standard. Tumor bed regions identified by fluorescence will be compared with pathological mapping of tumor, regression bed, and residual tumor distribution.
From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)
Diagnostic performance of preoperative FAPI PET for treatment response assessment
Time Frame: From preoperative imaging to postoperative pathological assessment (within 4 weeks)
To evaluate the ability of preoperative FAPI PET imaging to predict pathological response after neoadjuvant therapy, using pathological response (pCR/MPR/non-MPR) as the reference standard.
From preoperative imaging to postoperative pathological assessment (within 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between fluorescence signal intensity and pathological features
Time Frame: Postoperative specimen analysis (within 2-3 weeks after surgery)
To evaluate the correlation between fluorescence signal intensity and pathological parameters, including tumor cell density, regression bed, and FAP expression (e.g., immunohistochemistry), across tumor (T), margin (M), and normal (N) regions.
Postoperative specimen analysis (within 2-3 weeks after surgery)
Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens
Time Frame: Postoperative specimen analysis (within 2-3 weeks after surgery)
To quantify fluorescence signal contrast between tumor, tumor margin, and normal tissues, and determine optimal thresholds for tumor bed delineation.
Postoperative specimen analysis (within 2-3 weeks after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Kezhong Chen, MD, Peking University People's Hospital
  • Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital
  • Study Chair: Jun Wang, M.M., Peking University People's Hospital
  • Principal Investigator: Yuan Li, MD, Peking University People's Hospital
  • Principal Investigator: Hao Li, MD, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2101000672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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